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Class 2 Device Recall P.F.C. |
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Date Initiated by Firm |
May 26, 2005 |
Date Posted |
August 12, 2005 |
Recall Status1 |
Terminated 3 on December 02, 2005 |
Recall Number |
Z-1187-05 |
Recall Event ID |
32192 |
510(K)Number |
K033272
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Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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Product |
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-24-015. |
Code Information |
Lots Y58F14 and YY5BH4. |
Recalling Firm/ Manufacturer |
Depuy Orthopaedics, Inc. 700 Orthopaedic Dr Warsaw IN 46582-3994
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For Additional Information Contact |
800-366-8143
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Manufacturer Reason for Recall |
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
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FDA Determined Cause 2 |
Other |
Quantity in Commerce |
18 |
Distribution |
Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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